Safety, quality and regulatory compliance in every clinical data

The information security, the protection of clinical data and the quality of our processes are fundamental pillars of the Better Care strategy. Our technological solutions are developed and operated under demanding international standards, with regular audits carried out by independent entities.

National Security Scheme (ENS — Spain)

Better Care solutions meet the high safety levels defined by the ENS, ensuring the confidentiality, integrity, traceability and availability of health information, both in public and private environments.

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ISO/IEC 27001 — Information Security Management

The certification ISO/IEC 27001 proves that Better Care has implemented and maintains a Information Security Management System (ISMS) robust and continuously improving.

Download ISO/IEC 27001 certificate

ISO/IEC 27701 — Information Privacy Management

ISO/IEC 27701 expands the approach to security by incorporating the privacy management and personal data protection, especially relevant in the healthcare field.

Download ISO/IEC 27701 certificate

ISO/IEC 13485 — Quality Management System for Medical Devices

The ISO 13485 certification guarantees that Better Care has a specific Quality Management System for medical devices, aligned with international regulatory requirements.

Download ISO/IEC 13485 certificate

MDSAP — Medical Device Single Audit Program

The MDSAP allows a single audit to be recognized by multiple international regulatory authorities (such as the United States, Canada, Australia, Japan or Brazil).

Download MDSAP certificate

CE seal — European Community

The CE marking certifies that BC Link^® complies with the essential safety, operational and compliance requirements established by European regulations applicable to medical devices.

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Health Canada License

Compliance with Health Canada certifies that BC Link^® meets Canadian regulatory requirements for safety, efficacy and quality applicable to medical devices.

Download Health Canada certificate